The expansion comes as part of a move by the custom manufacturing and service business unit of Sigma Aldrich to create redundant manufacturing capabilities with its existing dry powder media facility in Lenexa, Kansas. The redundancy will allow SAFC’s top EU clients to save in shipping costs of bulk dry powder, Deborah Slagle, vice president of R&D, told in-Pharmatechnologist.com.
“The number one reason [for the expansion] is providing true redundancy for our customers,” Slagle said. A similar expansion at the Kansas facility took place two years ago when the company brought on two additional powder media lines there, she added. “It’s the same processes, same procedures, same validation packages, [and] same raw materials” as the expansion in Kansas, Slagle said.
“It also increases lead time and flexibility” for European companies.
A lot of companies in the EU are “ready to qualify us for the material” that they requested verbally and “they’re very interested in transferring some of the manufacturing product from Lenexa to Irvine” and that’s the next step, in terms of having both liquid and powder capabilities in the US and EU, Slagle said.
The dry powder media facility in Irvine is going to drive growth through 2020, Slagle said. Ground will be broken at the facility later this month and manufacturing should begin in the first quarter of 2014, according to the company.
Asian Interest in Biosimilars
Recently, SAFC’s CHOZN Platform system -- a CHO (Chinese Hamster Ovary) cell expression system that allows for faster, simpler selection and scale-up of clones for the production of recombinant protein drugs – also has received a lot of interest from clients in the Asian and Pacific regions.
Slagle explained the recent interest in the platform is related to companies looking to advance their biosimilar development programs, especially in markets that are less regulated than those in the Western world.
“We don’t know for certain, but it looks like they’re looking to develop biosimilars for the local markets,” Slagle said.
For these companies, SAFC is also finding it increasingly necessary “to not only provide products, whether it’s the engineered cell lines for production,” but technical R&D support and consulting services, she added.
Raw Material Expansion
SAFC on Monday also announced the addition of 20 raw materials to its catalogue for biopharmaceutical manufacturing. And by the end of this year, the PharmaGrade portfolio of high quality buffers, amino acids and specialty chemicals is expected to double in size to 80 raw materials.
Sigma-Aldrich’s acquisition of Research Organics in April 2012 contributed to the program’s resources and capabilities to further support increased market demand for new PharmaGrade raw materials.